Orange Book product · Generic (ANDA)
BENDAMUSTINE HYDROCHLORIDE
BENDAMUSTINE HYDROCHLORIDE
At a glance
Apr 28, 2023
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 28, 2023
3 yr 2 mo ago
Today
Pharmaceutical detail
Active ingredient
BENDAMUSTINE HYDROCHLORIDE
Strength
25MG/VIAL
Dosage form
POWDER
Route
INTRAVENOUS
TE code
Not listed
Application
ANDA 204104
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of BENDAMUSTINE HYDROCHLORIDE
- 2025BENDAMUSTINE HYDROCHLORIDEBrand (NDA)
NDA 219014 · AVYXA HOLDINGS
- 2022BENDAMUSTINE HYDROCHLORIDEBrand (NDA)
NDA 216078 · BAXTER HLTHCARE CORP
- 2022BENDAMUSTINE HYDROCHLORIDEBrand (NDA)
NDA 211530 · HOSPIRA
- 2022BENDAMUSTINE HYDROCHLORIDEBrand (NDA)
NDA 215033 · APOTEX
- 2022VIVIMUSTABrand (NDA)
NDA 212209 · AZURITY
- 2018BELRAPZOBrand (NDA)
NDA 205580 · EAGLE PHARMS
- 2015BENDEKABrand (NDA)
NDA 208194 · EAGLE PHARMS
- 2009TREANDABrand (NDA)
NDA 022249 · CEPHALON
- 2023BENDAMUSTINE HYDROCHLORIDEGeneric (ANDA)
ANDA 206554 · NANG KUANG PHARM CO
- 2023BENDAMUSTINE HYDROCHLORIDEGeneric (ANDA)
ANDA 204230 · APOTEX
- 2023BENDAMUSTINE HYDROCHLORIDEGeneric (ANDA)
ANDA 214739 · EUGIA PHARMA
- 2023BENDAMUSTINE HYDROCHLORIDEGeneric (ANDA)
ANDA 211001 · MEITHEAL
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
